Trajectories of Health in Spanish Population

Aging Clinical Trial

Official title:

Longitudinal Trajectories of Health, Disability and Well-being in Spanish Ageing Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343886
• Other study ID #: COURAGE2020
• Secondary ID: FP7/2007-2013- 3
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: November 10, 2017
• Start date: July 2011
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: Maria Cabello, PhD
• Phone: +34 914972447
• Email: maria.cabello[@]uam.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Age with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. Two waves have carried out so far. Wave 1 (2011-2012) and Wave 2 (2014-2015). Wave 3 will be conducted 2018, including also a new cohort of participants (Called 2018 Cohort). The study will provide reliable measures of population ageing and adult health in Spain - and will provide the basis for cross-country comparisons with longitudinal studies conducted in other countries.

Description:

Study Design:

A prospective cohort general population study. Three study Waves

Sample:

Wave 1: A nationally representative sample of non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed; four strata based on the number of inhabitants of the municipalities were built for each of the 17 Spanish autonomous communities. Clusters were selected within the strata with a probability of inclusion relative to their size. Within each cluster, households were randomly selected from a list of all households. In case there was more than one individual from the corresponding age group in the household, a random method was employed to select the individual participant. A total of 4,753 respondents were interviewed and signed the written consent.

Wave 2: Wave 1 sample was re-interviewed (Wave 2) in 2014-2015. The mean follow-up period was 3.5 years (SD = 0.18). A total of 2,528 individuals were re-interviewed. The response rate in the second wave was 69.5%. This cohort will be re-interviewed after 3.5 years (Wave 3).

Wave 3: Following the same sampling methods than in Wave 1 approximately 3000 participants from Madrid and Barcelona will be interviewed for the first time.

Data collection:

Face-to-face interviews by Computer-Assisted Personal Interviewing at the respondents' homes by trained interviewers. All interviewers receive a standardized training. Data quality control is also performed.

Main objective:

To assess trajectories of general health, disability and well-being in Spanish ageing population.

Secondary objectives:

To identify trajectories of healthy ageing (in terms of psychical health, mental health, functioning and well-being) in Spanish adult population as well as their determinants To analyse prevalence and impact of chronic health conditions, mental health problems, well-being and loneliness on mortality in Spanish adult population.

To determine risk factors for incidence and persistence of mental and physical health problems in Spanish ageing population.

Hypothesis:

The trajectories of health, functioning and well-being will be encompassed by relevant environmental factors such as social support, loneliness and health care utilization, personal factors (socio-demographic characteristics, healthy lifestyles, and high cognitive reserve among others) and other biological and health-related factors (weight, height, waist circumference, executive functions, blood pressure, grip strength, vision acuity, presence of mental and physical health problems and quality of life).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-institutionalized Spanish residents

• 18 years and over

Exclusion Criteria:

• Institutionalized population

Related Conditions & MeSH terms

• Aging
• Chronic Disease
• Disability, Evaluation
• Health, Subjective
• Mental Disorder
• Mental Disorders
• Mental Health Wellness 1
• Psychotic Disorders

Locations

Country	Name	City	State
Spain	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Madrid
Spain	Fundació Sant Joan de Déu	Sant Boi De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

References & Publications (31)

Ayuso-Mateos JL, Miret M, Caballero FF, Olaya B, Haro JM, Kowal P, Chatterji S. Multi-country evaluation of affective experience: validation of an abbreviated version of the day reconstruction method in seven countries. PLoS One. 2013 Apr 23;8(4):e61534. — View Citation

Caballero FF, Miret M, Power M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Olaya B, Haro JM, Ayuso-Mateos JL. Validation of an instrument to evaluate quality of life in the aging population: WHOQOL-AGE. Health Qual Life Outcomes. 2013 Oct 23 — View Citation

Garin N, Olaya B, Lara E, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Visual impairment and multimorbidity in a representative sample of the Spanish population. BMC Public Health. 2014 Aug 8;14:815. doi: 10.1186/1471-2458-14-815. — View Citation

Garin N, Olaya B, Miret M, Ayuso-Mateos JL, Power M, Bucciarelli P, Haro JM. Built environment and elderly population health: a comprehensive literature review. Clin Pract Epidemiol Ment Health. 2014 Oct 21;10:103-15. doi: 10.2174/1745017901410010103. eCo — View Citation

Garin N, Olaya B, Moneta MV, Miret M, Lobo A, Ayuso-Mateos JL, Haro JM. Impact of multimorbidity on disability and quality of life in the Spanish older population. PLoS One. 2014 Nov 6;9(11):e111498. doi: 10.1371/journal.pone.0111498. eCollection 2014. — View Citation

Garin N, Olaya B, Perales J, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Multimorbidity patterns in a national representative sample of the Spanish adult population. PLoS One. 2014 Jan 20;9(1):e84794. doi: 10.1371/journal.pone.0084794. eCollection 2014. — View Citation

Kamenov K, Caballero FF, Miret M, Leonardi M, Sainio P, Tobiasz-Adamczyk B, Haro JM, Chatterji S, Ayuso-Mateos JL, Cabello M. Which Are the Most Burdensome Functioning Areas in Depression? A Cross-National Study. Front Psychol. 2016 Aug 31;7:1342. doi: 10 — View Citation

Koyanagi A, Stickley A, Garin N, Miret M, Ayuso-Mateos JL, Leonardi M, Koskinen S, Galas A, Haro JM. The association between obesity and back pain in nine countries: a cross-sectional study. BMC Public Health. 2015 Feb 11;15:123. doi: 10.1186/s12889-015-1 — View Citation

Lara E, Koyanagi A, Caballero F, Domènech-Abella J, Miret M, Olaya B, Rico-Uribe L, Ayuso-Mateos JL, Haro JM. Cognitive reserve is associated with quality of life: A population-based study. Exp Gerontol. 2017 Jan;87(Pt A):67-73. doi: 10.1016/j.exger.2016. — View Citation

Lara E, Koyanagi A, Domènech-Abella J, Miret M, Ayuso-Mateos JL, Haro JM. The Impact of Depression on the Development of Mild Cognitive Impairment over 3 Years of Follow-Up: A Population-Based Study. Dement Geriatr Cogn Disord. 2017;43(3-4):155-169. doi: — View Citation

Lara E, Koyanagi A, Olaya B, Lobo A, Miret M, Tyrovolas S, Ayuso-Mateos JL, Haro JM. Mild cognitive impairment in a Spanish representative sample: prevalence and associated factors. Int J Geriatr Psychiatry. 2016 Aug;31(8):858-67. doi: 10.1002/gps.4398. E — View Citation

Lara E, Olaya B, Garin N, Ayuso-Mateos JL, Miret M, Moneta V, Haro JM. Is cognitive impairment associated with suicidality? A population-based study. Eur Neuropsychopharmacol. 2015 Feb;25(2):203-13. doi: 10.1016/j.euroneuro.2014.08.010. Epub 2014 Aug 21. — View Citation

Leonardi M, Chatterji S, Koskinen S, Ayuso-Mateos JL, Haro JM, Frisoni G, Frattura L, Martinuzzi A, Tobiasz-Adamczyk B, Gmurek M, Serrano R, Finocchiaro C; COURAGE in Europe Project's Consortium. Determinants of health and disability in ageing population: — View Citation

Martín-María N, Caballero FF, Olaya B, Rodríguez-Artalejo F, Haro JM, Miret M, Ayuso-Mateos JL. Positive Affect Is Inversely Associated with Mortality in Individuals without Depression. Front Psychol. 2016 Jul 12;7:1040. doi: 10.3389/fpsyg.2016.01040. eCo — View Citation

Martín-María N, Miret M, Caballero FF, Rico-Uribe LA, Steptoe A, Chatterji S, Ayuso-Mateos JL. The Impact of Subjective Well-being on Mortality: A Meta-Analysis of Longitudinal Studies in the General Population. Psychosom Med. 2017 Jun;79(5):565-575. doi: — View Citation

Miret M, Caballero FF, Chatterji S, Olaya B, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM, Ayuso-Mateos JL. Health and happiness: cross-sectional household surveys in Finland, Poland and Spain. Bull World Health Organ. 2014 Oct 1;92(10):716-25. doi — View Citation

Miret M, Caballero FF, Huerta-Ramírez R, Moneta MV, Olaya B, Chatterji S, Haro JM, Ayuso-Mateos JL. Factors associated with suicidal ideation and attempts in Spain for different age groups. Prevalence before and after the onset of the economic crisis. J A — View Citation

Miret M, Caballero FF, Olaya B, Koskinen S, Naidoo N, Tobiasz-Adamczyk B, Leonardi M, Haro JM, Chatterji S, Ayuso-Mateos JL. Association of experienced and evaluative well-being with health in nine countries with different income levels: a cross-sectional — View Citation

Olaya B, Moneta MV, Démenech-Abella J, Miret M, Bayes I, Ayuso-Mateos JL, Haro JM. Mobility difficulties, physical activity and all-cause mortality risk in a nationally-representative sample of older adults. J Gerontol A Biol Sci Med Sci. 2017 Jun 19. doi — View Citation

Olaya B, Moneta MV, Koyanagi A, Lara E, Miret M, Ayuso-Mateos JL, Chatterji S, Leonardi M, Koskinen S, Tobiasz-Adamczyk B, Lobo A, Haro JM. The joint association of depression and cognitive function with severe disability among community-dwelling older ad — View Citation

Perales J, Martin S, Ayuso-Mateos JL, Chatterji S, Garin N, Koskinen S, Leonardi M, Miret M, Moneta V, Olaya B, Tobiasz-Adamczyk B, Haro JM. Factors associated with active aging in Finland, Poland, and Spain. Int Psychogeriatr. 2014 Aug;26(8):1363-75. doi — View Citation

Quintas R, Raggi A, Bucciarelli P, Franco MG, Andreotti A, Caballero FF, Olaya B, Chatterji S, Galas A, Meriläinen-Porras S, Frisoni G, Russo E, Minicuci N, Power M, Leonardi M. The COURAGE Built Environment Outdoor Checklist: an objective built environme — View Citation

Raggi A, Corso B, Minicuci N, Quintas R, Sattin D, De Torres L, Chatterji S, Frisoni GB, Haro JM, Koskinen S, Martinuzzi A, Miret M, Tobiasz-Adamczyk B, Leonardi M. Determinants of Quality of Life in Ageing Populations: Results from a Cross-Sectional Stud — View Citation

Raggi A, Quintas R, Bucciarelli P, Franco MG, Andreotti A, Miret M, Zawisza K, Olaya B, Chatterji S, Sainio P, Frisoni GB, Martinuzzi A, Minicuci N, Power M, Leonardi M. Validation of the COURAGE Built Environment Self-Reported Questionnaire. Clin Psychol — View Citation

Raggi A, Quintas R, Russo E, Martinuzzi A, Costardi D, Frisoni GB, Franco MG, Andreotti A, Ojala M, Peña S, Perales J, Chatterji S, Miret M, Tobiasz-Adamczyk B, Koskinen S, Frattura L, Leonardi M. Mapping SAGE questionnaire to the International Classifica — View Citation

Rico-Uribe LA, Caballero FF, Olaya B, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM, Chatterji S, Ayuso-Mateos JL, Miret M. Loneliness, Social Networks, and Health: A Cross-Sectional Study in Three Countries. PLoS One. 2016 Jan 13;11(1):e0145264. do — View Citation

Tyrovolas S, Koyanagi A, Garin N, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Determinants of the components of arterial pressure among older adults--the role of anthropometric and clinical factors: — View Citation

Tyrovolas S, Koyanagi A, Garin N, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Diabetes mellitus and its association with central obesity and disability among older adults: a global perspective. Exp — View Citation

Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Factors associated with skeletal muscle mass, sarcopenia, and sarcopenic obesity in older adults: a multi-continent study. J Cach — View Citation

Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. The role of muscle mass and body fat on disability among older adults: A cross-national analysis. Exp Gerontol. 2015 Sep;69:27-35 — View Citation

Zawisza K, Galas A, Tobiasz-Adamczyk B, Chatterji S, Haro JM, Miret M, Koskinen S, Power M, Leonardi M. The validity of the instrument to evaluate social network in the ageing population: the Collaborative Research on Ageing in Europe Social Network Index — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Wave 1 Alcohol use	Construct: Alcohol use Measure: Self-reported information of how many standard drinks per day in last 7 days have been used.; Values: four categories of alcohol use: 0= Lifetime abstainers: Participants that have never used alcohol; Occasional drinkers: Participants that have ever used alcohol but not in the previous 7 days; Infrequent heavy drinker: Participants did consume alcohol 1-2 days per week, with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.; Frequent heavy drinkers: Participants did consume alcohol 3 or more days per week with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.	Three times (each 3.5 years)
Other	Change from Wave 1 Tobacco use	Construct: Tobacco use Measure: Self-reported information of how many cigarettes/pipes/tobacco products/ have been used in the last week.; Values: Four categories of tobacco use: 0=Never smokers: Participants that have never used tobacco; Non daily smokers: Participants that have ever used tobacco but not in the previous week; Daily smokers: Participants that have used tobacco last week	Three times (each 3.5 years)
Other	Change from Wave 1 Physical activity	Construct: Level of physical activity Scale: Global Physical Activity Questionnaire version 2 (GPAQ v2) Values: Three values of physical activity can be obtained 3=High physical activity 2=Moderate physical activity; 1=Low physical activity	Three times (each 3.5 years)
Other	Change from Social Support	Construct: Social Support Measure: 3-Item Oslo Social Support Scale (Abiola, 2013) Result: A global total Score Range: 3-14. 3 means lower social support	Three times (each 3.5 years)
Other	Change from wave 1 Loneliness	Construct: Loneliness Measure: Three-item University of California, Los Angeles (UCLA) Loneliness Scale (Hughes et al, 2004) Result: A total loneliness score Range: 3-9. Higher scores means higher loneliness	Three times (each 3.5 years)
Other	Change from Wave 1 Size of Social network	Construct: Size of Social Network Measure: Berkman-Syme Social Network Index Result: A Total score Range: 0-99. Higher score indicate bigger network that lower score	Three times (each 3.5 years)
Other	Change from Wave 1 Weight	Construct: Weight Result: kilograms	Three times (each 3.5 years)
Other	Change from Wave 1 Height	Construct: Height Measure: Centimeters	Three times (each 3.5 years)
Other	Change from Wave 1 Waist circumference	Construct: Waist circumference. Measure: Centimeters	Three times (each 3.5 years)
Other	Change from Wave 1 Handgrip	Construct: Handgrip. Measure: Smedley Hand Dynamometer (Stoelting Company). Result: Kilogram	Three times (each 3.5 years)
Other	Change from Wave 1 Gait speed	Construct: Gait speed. Measure: Gaid speed test. Result: Metres per second.	Three times (each 3.5 years)
Other	Change from Wave 1 Cognitive Reserve	Construct: Reserve Cognitive. Measure: Cognitive Reserve Questionnaire (CRQ, Rami, et al 211) Result: A Total score. Range 0-25 Higher scores means higher cognitive reserve	Three times (each 3.5 years)
Primary	Change from Wave 1 Heath Status	Measure: Health composite total score (Salomon, 2003). Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.	Three times (each 3.5 years)
Primary	Change from Wave 1 Disability	Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). (World Health Organization, 2010). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability	Three times (each 3.5 years)
Primary	Change from Wave 1 Instrumental Activities of Daily living	Measure: Instrumental Activities of Daily Living Scale (Lawton & Brody, 1969). Construct: Instrumental activities of daily living. Final result: A global total score. Range 0-8. 0 means higher problems to perform activities.	Three times (each 3.5 years)
Primary	Change from Wave 1 Activities of Daily Living	Measure: The Barthel Index (Van der Putten, 1999). Construct: Activities of Daily Living. Result: A global total score. Range 0-100. 0 means higher problems to perform activities.	Three times (each 3.5 years)
Primary	Change from Wave 1 Experienced Well-being	Abbreviated Version of the Day Reconstruction Method (Miret, et al., 2012). Construct: Experienced wellbeing.; Final Result: The used scale reports two global scores: Positive Affect total score. Range: 0-100 where 0 means lower positive affect.; Negative Affect total score. Range 0-100 where 0 means lower negative affect.	Three times (each 3.5 years)
Primary	Change from Wave 1 Quality of life	Measure: World Health Organization Quality of Life-Age (WHOQOL-AGE) (Caballero, et al., 2013). Construct: Quality of life. Final Result: A global total score. Range 0-100. 0 means lower quality of life	Three times (each 3.5 years)
Primary	Change from Wave 1 Eudaimonic Well-being	Measure: The Flourishing Scale (Diener, et al., 2009). Construct: Eudaimonic Wellbeing. Final result: The scale used shows a total score. Range 8-56. 8 means lower eudaimonic well-being	Three times (each 3.5 years)
Secondary	Change from Wave 1 Depression	Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Depression module (WHO-CIDI, 1990).; Construct: Presence of Depression. Final result: Two measures of depression according to Research Diagnostic Criteria.; Presence of 12 month depression. Values (yes/no).; Presence of lifetime depression. Values (yes/no).	Three times (each 3.5 years)
Secondary	Change from Wave 1 Suicide behavior	Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Suicide module (WHO-CIDI, 1990).; Construct: Presence of Suicide behavior The instrument reports six measures of suicide behavior.; Presence of 12 month suicide ideation. Values (yes/no); Presence of 12 month suicide planning. Values (yes/no); Presence of 12 month suicide attempts. Values (yes/no); Presence of lifetime suicide ideation. Values (yes/no); Presence of lifetime suicide planning. Values (yes/no); Presence of lifetime suicide attempts. Values (yes/no)	Three times (each 3.5 years)
Secondary	Change from Wave 1 Anxiety	Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Anxiety disorders module (WHO-CIDI, 1990).; Construct: Presence of anxiety Disorders Final Result: The instrument included in the study reports six measures of anxiety disorders according to Research diagnostic criteria.; Presence of 12 month panic disorder. Values (yes/no); Presence of 12 month generalized anxiety disorder. Values (yes/no); Presence of 12 month phobic disorder. Values (yes/no); Presence of lifetime panic disorder. Values (yes/no); Presence of lifetime generalized anxiety disorder. Values (yes/no); Presence of lifetime phobic disorder. Values (yes/no)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of diabetes	Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of osteoarthritis	Construct: Presence of osteoarthritis Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for osteoarthritis Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of any lung disease	Construct: Presence of any lung disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any lung disease Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of stroke	Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of chest angina	Construct: Presence of chest angina Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for chest angina Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of arthritis	Construct: Presence of arthritis Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for arthritis.; Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 Blood pressure	Construct: Blood pressure Measure: Blood pressure monitor	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of cataracts	Construct: Presence of cataracts Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for cataracts Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of asthma	Construct: Presence of asthma Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for asthma Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of kidney disease	Construct: Presence of any kidney disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for kidney disease.; Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of liver disease	Construct: Presence of liver disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for liver disease Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of cancer	Construct: Presence of any kind of cancer Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any kind of cancer Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of anaemia	Construct: Presence of anaemia Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for anaemia.; Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of thyroid problems	Construct: Presence of any thyroid problems Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any thyroid problems.; Values: (Yes/No)	Three times (each 3.5 years)
Secondary	Change from Wave 1 presence of glaucoma	Construct: Presence of glaucoma Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for glaucoma. Values: (Yes/No)	Three times (each 3.5 years)

External Links

•   Age with health website info